Ethics approval
The FIDEL study was conducted in accordance with the principles of the
Helsinki Declaration and its subsequent amendments and Good Clinical
Practices (CPMP/ICH/135/95). It was approved by an independent French
Ethics Committee (Comité de Protection des Personnes Nord Ouest
IV , approval given on December 10, 2013) as required by French law19,23.
The research was also submitted to the
French Regulatory Agency
(Agence Nationale de Sécurité du Médicament et des produits de
santé ). Authorisation was given on November 25, 2013.
Given the emergency context, consent to participate was obtained after
brief delivery of information to the patient, or a relative or reliable
person, depending on the patient’s level of consciousness. In all cases,
as soon as possible, the patient was fully informed about the study and
asked to sign a post-inclusion consent form to continue participating.
The FIDEL study was registered in the European and US trial databases
under Eudract No. 2013-002484-26 and NCT02155725, respectively.